Effect of Omega-3 PUFA Supplementation in NAFLD Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00230113
First received: September 29, 2005
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids will decrease the amount of fat in liver.


Condition Intervention Phase
Non-Alcoholic Fatty Liver Disease
Dietary Supplement: Omega-3 fatty acid diet supplementation
Dietary Supplement: safflower oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Randomized, Masked, Controlled Study of Omega-3 Polyunsaturated Fatty Acid vs Monounsaturated Fatty Acid Diet Supplementation for the Treatment of Nonalcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy [ Time Frame: 2 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum aminotransferase levels Change in lipid profile Change in levels of proinflammatory cytokines [ Time Frame: 2 month ] [ Designated as safety issue: No ]
  • Change in insulin resistance determined by HOMA [ Time Frame: 2 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Dietary Supplement: Omega-3 fatty acid diet supplementation
4 gm fish oil per day
Placebo Comparator: 2 Dietary Supplement: safflower oil
4 gm per day safflower oil

Detailed Description:

NAFLD is the most common liver disease in the United States and is also a common cause of abnormal liver tests in the United States. NAFLD includes mild as well as a more severe nonalcoholic fatty liver disease involving liver cell inflammation and damage, called Nonalcoholic Steatohepatitis (NASH). NAFLD is usually discovered because of abnormal liver tests or from a liver ultrasound or CT scan in persons with normal liver enzymes. Liver biopsy may show a mix of fat, inflammation and scarring in the liver. Patients with NAFLD do not drink large amounts of alcohol that can cause this type of liver damage. NAFLD is thought to be related to obesity and diabetes. Unfortunately, there is very little information about important features of NAFLD. These include biochemical, genetic and other features that may help to predict disease progression. The few known risk factors include high blood sugar and lipid levels. Patients with NAFLD often have resistance to the normal action of insulin, a hormone which is important for processing sugar and fat. Increased resistance to insulin leads to fat in the liver. Currently, there is no proven treatment for NAFLD. Several studies in animals suggest that diets containing high levels of omega-3 polyunsaturated fatty acids (PUFA) will decrease the amount of liver fat.

It has long been known that omega-3 fatty acids have several health benefits. For example, a diet rich in these fatty acids reduces the amount of certain fats ("triglycerides") in blood, and might improve the action of the important hormone insulin. Omega-3 fatty acids are contained in certain plant oils (such as canola oil and linseed oil) and marine fish (such as salmon). The purpose of this study is to determine the effect of dietary supplementation with ω-3 polyunsaturated vs monounsaturated fatty acids on intrahepatic fat content in patients with non-alcoholic fatty liver disease as determined by magnetic resonance spectroscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acceptance into NASH CRN Database Study
  • Exclusion from or unwillingness to participate in the NASH CRN PIVENS Study
  • Histological diagnosis or imaging study suggesting NAFLD with at least 20% steatosis
  • Willingness to maintain study diet for duration of the study
  • At least 18 years of age
  • No contraindication for MRI scanning (i.e., pacemaker, shunts etc)

Exclusion Criteria:

  • Use of lipid lowering drugs (i.e., statins and fibrate drugs)
  • Use of insulin or thiazolidinediones
  • Use of drugs possibly associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, or other known hepatotoxins) for more than 2 consecutive weeks in the 2 years prior to screening
  • Initiation of anti-diabetic drugs (insulin, biguanides, sulfonylureas, metformin, thiazolidinediones) in the 3 months prior to randomization
  • Initiation of anti-NASH drugs (thiazolidinediones, vitamin E, metformin, UDCA, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies, probiotics) in the 3 months prior to randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230113

Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Investigators
Principal Investigator: Kris V Kowdley, MD University of Washington
  More Information

No publications provided

Responsible Party: Kris Kowdley MD, Virginia Mason Medical Center
ClinicalTrials.gov Identifier: NCT00230113     History of Changes
Other Study ID Numbers: DK61728-S2
Study First Received: September 29, 2005
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
NAFLD
NASH
Fatty Liver Disease
Omega-3 Fatty Acid
Fish oil

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014